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Completed

NCT Number: NCT01771666

Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer

The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University, School of Medicine

Stanford, California, 94305, United States

About this study

It is the objective of the current study to test Indocyanine Green (IC-GREEN) as an agent for mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the setting of sentinel node procedures with or without axillary node dissections in women with breast cancer. All participants will also have tumor samples evaluated with 99technetium-sulfur colloid, a radiolabel used to identify tumor markers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to understand and the willingness to sign a written informed consent document.
  • Signed written informed consent.
  • Women undergoing sentinel lymph node biopsy.
  • Women with breast cancer with known or suspected lymph node involvement.
  • Women undergoing sentinel node identification and completion axillary lymph node dissection.
  • Women of 18 years of age or older.
  • Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2.
  • Complete Blood Count (CBC) and basic Metabolic Panel within 6 months

Exclusion criteria

  • History of liver or kidney failure will not be eligible.
  • Allergies to iodine containing products will not be eligible.
  • Women who are pregnant will not be eligible.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Treatment and study plan

SPY Elite Imaging

Device

A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes

Indocyanine green

Drug

started at 1mg /mL

If fluorescence is not detected with this dose, then it will be increased by 50%.

Other names: IC-GREEN, ICG

isosulfan blue

Drug

3 to 5 mL

If fluorescence is not detected with this dose, then it will be increased by 50%.

Other names: IS-BLUE, ISB, Lymphazurin

99technetium-sulfur colloid radiolabel

Drug

Other names: 99tech

Primary outcomes

  1. Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)

    Time frame: 1 day

    Number of women with agreement of the two dies [ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent.

Secondary outcomes

  1. Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes

    Time frame: 1 day

    The outcome is expressed as the number of participants whose resected sentinel lymph nodes (SLN) bound 99technetium-sulfur colloid (99tech), a tumor marker radiolabel; Indocyanine Green (IC-GREEN; "GREEN"), a fluorescent label; or isosulfan blue (IS-BLUE; "BLUE"), a visual dye. Results are expressed as:

    • "Any HOT" = Those whose samples bound 99tech.
    • "Not HOT" = Those whose samples did not bind 99tech.
    • "Not HOT (also no BLUE, no GREEN)" = Those whose samples did not bind 99tech; and also did not bind IC-GREEN nor IS-BLUE.
    • "HOT, BLUE, GREEN" = Those whose samples bound all of 99tech; IC-GREEN; and IS-BLUE.
    • "HOT, no BLUE, no GREEN" = Those whose samples bound 99tech, but did not bind either of IC-GREEN nor IS-BLUE.
    • "HOT, GREEN only, no BLUE" = Those whose samples bound 99tech and IC-GREEN, but did not bind IS-BLUE.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

A Pilot Study to Assess the Utility of Indocyanine Green™ (IC-GREEN™) SPY Imaging in the Mapping of Arm Draining Lymphatics and Nodes During Sentinel Node Resection With or Without Axillary Dissection in Breast Cancer

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 18, 2013
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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